I Manage this role : Angela Murphy
The ARM Group is seeking a Full-Time, Quality Assurance & Quality Management System Supervisor for one of our leading Personal Care Products Industry leading customers in Aurora, IL.
Reports To: Plant Quality Head
Pay Rate – $110,000.00 + Annually.
Job Summary:
The QA & QMS Supervisor is responsible for ensuring effective deployment of the Quality Assurance program and Quality Management System within a contract manufacturing environment for cosmetics and OTC drug products. This role ensures all customers and regulatory requirements are consistently met in accordance with ISO 22716 (Cosmetic GMP), MoCRA and 21 CFR Parts 210 & 211 (cGMP for pharmaceuticals). The successful candidate will serve as a key liaison between internal teams and external customers, driving quality compliance, continuous improvement, and audit readiness across the contract manufacturing plant.
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Key Responsibilities:
· Lead the implementation, maintenance, and continuous improvement of Quality Management System (QMS) in accordance with ISO 22716 and 21 CFR Part 210 & 211, and customers’ expectations at the manufacturing site.
· Manage a team of 3-4 Quality assurance specialists, assigning tasks and deliverables.
· Maintain and manage the annual Site registration Per MoCRA and OTC with the FDA.
· Update annual product listing with the FDA for cosmetics and OTC products.
· Author and maintain Annual Product reviews (APR’s) for OTC products.
· Escalation of major non-conformances and customer complaints to Quality head and site leadership.
· Develop, deploy & sustain a comprehensive Quality Assurance program, by establishing the appropriate policies, standards, procedures, and controls, that ensure reliable supply of quality products consistently, conforming to the established standards, regulatory requirements, and customers’ expectations.
· Act as a key point of contact for customers’ quality teams, ensuring all customer-specific requirements and clauses of quality agreements are fulfilled.
· Be responsible for the end-to-end quality oversight of warehousing, dispensing, compounding, manufacturing, packaging, labelling, releases & shipment of all cosmetics and OTC products produced at the manufacturing site.
· Review and approve the Master Batch Records, executed batch documentation, QC test reports, deviations, CAPAs, and change controls.
· Host & manage the internal, customer, regulatory and certification agency audits including preparation, execution, response coordination, and CAPA implementation.
· Conduct investigations into deviations, complaints, and OOS results; ensure thorough root cause analysis and timely & effective CAPA closure.
· Deploy effective in-process Quality Assurance checks & measures on the shop floor to sustain the GMP standards and product quality attributes.
· Ensure ongoing compliance with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) for the plant.
· Develop and deliver GMP/QMS training to ensure staff remain up to date with quality standards and regulatory changes.
· Establish suitable processes & controls for new product introduction into plant.
· Maintain quality metrics, dashboards, and reporting for internal and customer review.
· Support validation and qualification of equipment, cleaning, and processes in alignment with customer requirements and regulatory guidelines.
· Implement appropriate vendor management program in accordance with customers’ requirements to ensure the quality of incoming materials.
· Be the custodian of all GXP documents & records, including those that are received from the customers.
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Deliverables:
· Successful outcome of Inspections & Audits by the Health Authority (USFDA), 3rd party certification agencies and customers (existing as well as prospective).
· All finished products released for shipment to the customers meet their established quality standards.
· Effective & Efficient deployment of Quality Management System ensuring sustained certifications for ISO 22716 and 21 CFR part 210 & 211.
Disclaimer:
The ARM GROUP is committed to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.
We actively encourage applications from individuals with diverse backgrounds, including people with disabilities. Accommodations are available upon request for applicants participating in all aspects of the selection process.
By applying for this job, you consent to allow representatives of ARM GROUP LLC to contact you regarding your candidacy. This may include communication via email, phone, text, or other means deemed appropriate by ARM GROUP LLC. Rest assured, your information will be handled confidentially and used solely for recruitment purposes.
It’s important to note that ARM Group LLC does not interfere in the decision-making process regarding your selection or rejection. The ultimate decision to hire or reject your candidacy lies solely with the client organization, with whom we have an agreement to source candidates for their consideration
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. All applicants must submit to background check and drug screening.
Applicants for this position must be legally authorized to work in the United States. Please be aware that this position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.